(79 days)
The Everbond® system is intended to bond composite and compomer restorative material to the tooth structure (dentin and enamel)
resin-based tooth bonding system, tradenamed Everbond®. The Everbond® system is intended to bond composite and compomer restorative material to the tooth structure (dentin and enamel), and is composed of an etching gel and a primer/bond formulation.
Here's a breakdown of the acceptance criteria and the study details for the Everbond® system, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided document describes the Everbond® system's substantial equivalence to predicate devices, focusing on shear bond strength. The acceptance criteria are implicitly that the Everbond® system's shear bond strength should be comparable to or not inferior to the predicate device, Dentsply's Multipurpose Dentin/Enamel Bonding Agent Bond & Prime 2.1®. While specific numerical acceptance thresholds are not explicitly stated, the study's purpose is to demonstrate substantial equivalence through comparison.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance (Everbond®) |
|---|---|---|
| Shear Bond Strength | Shear bond strength comparable to Dentsply's Bond & Prime 2.1® | Compared by two independent institutes to Bond & Prime 2.1® (Specific values not provided, but the submission implies successful comparison for substantial equivalence) |
| Material Composition | Composition substantially equivalent to ESPE's Pertac® II, Hytac®, and Hytac® OSB | Compositions were compared and found to be substantially equivalent. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "the shear bond strength of the Everbond® system has been compared to that of Bond & Prime 2.1º by two institutes," but does not specify the number of samples or specimens tested.
- Data Provenance:
- Country of Origin: USA (University of Houston, Texas) and Germany (University of Regensburg).
- Retrospective or Prospective: Not explicitly stated, but clinical testing for bond strength is typically prospective.
3. Number of Experts and Qualifications for Ground Truth
Not applicable for this type of device and study. The "ground truth" here is the measured shear bond strength, not expert interpretation of images or clinical outcomes requiring consensus. The "experts" involved are presumably the researchers and technicians at the two university institutes conducting the laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. Shear bond strength is a quantitative, objective measurement, not subject to adjudication in the same way as, for example, diagnostic image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a dental bonding agent, and its performance is evaluated through material properties like shear bond strength, not through human reader interpretation of cases.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical product (a bonding agent), not an algorithm or AI system.
7. Type of Ground Truth Used
- Shear Bond Strength: The ground truth is the direct measurement of bond strength through standardized laboratory testing methods (e.g., universal testing machine to apply shear force until failure).
- Material Composition: The ground truth is the chemical analysis of the composition of the materials.
8. Sample Size for the Training Set
Not applicable for this submission. The "training set" concept is typically relevant for machine learning algorithms. For a medical device like a dental bonding agent, the development process might involve iterative testing and refinement, but it's not formally referred to as training a model. The provided document focuses on the final validation of the product.
9. How Ground Truth for the Training Set Was Established
Not applicable. (See point 8). The "ground truth" for product development would be based on established dental material science principles, previous product data, and laboratory testing.
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DEC 1 6 1998
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS II.
ESPE is submitting a 510(k) premarket notification for its resin-based tooth bonding system, tradenamed Everbond®. The Everbond® system is intended to bond composite and compomer restorative material to the tooth structure (dentin and enamel), and is composed of an etching gel and a primer/bond formulation. The etching gel used in the Everbond® system is ESPE's 510(k) cleared MiniTip® Etching Gel (K810266). Concerning the intended use the priming/bonding agent is substantially equivalent to Dentsply's Multipurpose Dentin/Enamel Bonding Agent Bond & Prime 2.1® (K962348). Concerning the ingredients Everbond® is substantially equivalent to the formerly 510(k) cleared ESPE products Pertac® II (K962440), Hytac® (K962442), and Hytac® OSB (K962442). All predicate devices are well-established and determined to be safe, effective and beneficial.
To support substantial equivalence to Dentsply's predicate product Bond & Prime 2.1® the shear bond strength of the Everbond® system has been compared to that of Bond & Prime 2.1º by two institutes (J. Powers, University of Houston, Texas, USA and K .- H. Friedl, University of Regensburg, Germany).
To support substantial equivalence to ESPE's predicate products Pertac® II, Hytac® and Hytac® OSB the compositions have been compared.
ESPE's 510(k) has been submitted on September, 14, 1998 by Dr. Andreas Petermann at ESPE Platz, D-82229 Seefeld, Germany (011-49-8152-700395).
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines above it, possibly representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1368
Dr. A. Petermann Requlatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld/Oberbay GERMANY
Re : K983414 Everbond® Trade Name: Requlatory Class: II Product Code: KLE September 14, 1998 Dated: September 28, 1998 Received:
Dear Dr. Petermann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Petermann
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE lll.
| Device Name: | Everbond® (System) |
|---|---|
| - Everbond® (priming and bonding agent) | |
| - MiniTip® Etching Gel |
Indications for use:
Bonding of enamel/dentin and composite or compomer restorative materials.
Susan Renner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Prescription Use _ (Per 21 CFR 801.109)
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.